Liner and retaining member for use with respiratory mask

ABSTRACT

A respiratory mask includes a mask body having a face-engaging portion, and at least one retaining member connected to the mask body and including at least one engaging member for receiving and tethering a liner to the respiratory mask to generally overlie the face-engaging portion. The retaining member may include a flexible elongated body having a central portion and opposing ends, and a bottom surface arranged to be attached to the respiratory mask. The liner may include a liner body constructed from an absorbent material and having an outer edge, an inner edge, and an opening bounded by the inner edge, wherein an extending portion of the liner body is defined which extends outwardly beyond the face-engaging portion and includes at least one aperture for engaging the retaining member. A kit for use with a respiratory mask includes at least one liner and at least one retaining member.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. provisional application Ser.No. 62/648,895 filed Mar. 27, 2018, the disclosure of which is herebyincorporated in its entirety by reference herein.

TECHNICAL FIELD

Embodiments relate to a respiratory mask, a retaining member and linerfor use with a respiratory mask, and combinations thereof.

BACKGROUND

A respirator is used to protect a user from inhaling dangeroussubstances, such as chemicals and particulate matter. A respiratortypically includes a mask body for covering the user's nose and mouth,and one or more cartridges or canisters which include filters forremoving the dangerous substances from the air inhaled by the user. Mostrespirator masks currently available are made from silicone, rubber,vinyl, or a nylon-based fabric. These materials are typically water andgas impermeable which can block off pores, cause sweating, and createpressure marks on the face, causing discomfort for the user. Since manyusers wear respirators for a significant part of each day, they needmasks that are ergonomic and do not impose a physical burden even duringperiods of extended wear or environmental extremes such as hightemperature and humidity.

Obstructive sleep apnea is a serious and potentially fatal medicalcondition in which a person's airway becomes physically blocked multipletimes during sleep, restricting oxygen intake and causing the person toawake gasping for breath. Possible effects of the condition includeextreme fatigue, high blood pressure, strokes, heart attacks, andsometimes even death. One of the most common treatments of obstructivesleep apnea is the use of a continuous positive airway pressure (CPAP)machine. These machines deliver a continuous flow of pressurized air tothe airway through a hose and mask fitted to the face. Patientcompliance is a major problem with CPAP users, however, due todiscomfort, air leaks, and general ineffectiveness. It is estimated thatup to 50% of users discontinue use.

As with respirators, most CPAP masks currently available are made fromsilicone, rubber, vinyl, or a nylon-based fabric. These materials aretypically water and gas impermeable, which can block off pores, causesweating, and create pressure marks on the face, increasing thediscomfort of the mask. Furthermore, most mask manufacturers recommendagainst the use of skin or face cream with CPAP masks such the maskmaterial directly contacts the skin. This is a problem for many users,especially those that have dry skin and depend on night cream for skincare.

SUMMARY

In one or more embodiments, a respiratory mask includes a mask bodyhaving a face-engaging portion. At least one retaining member isconnected to the mask body, the at least one retaining member includingat least one engaging member for receiving a liner and tethering theliner to the respiratory mask to generally overlie the face-engagingportion.

In one or more embodiments, a retaining member for use with arespiratory mask includes a flexible elongated body having a centralportion and opposing ends on either side of the central portion, thebody having a bottom surface arranged to be attached to the respiratorymask. At least one engaging member extends from the body for receiving aliner and tethering the liner to the respiratory mask.

In one or more embodiments, a liner for use with a respiratory maskhaving a face-engaging portion and a retaining member includes a linerbody constructed from an absorbent material, the liner body having anouter edge, an inner edge, and an opening bounded by the inner edge.When the liner is positioned between the face-engaging portion and aface of a user, an extending portion of the liner body is defined whichextends outwardly beyond the face-engaging portion, the extendingportion including at least one aperture for engaging the retainingmember to tether the liner to the respiratory mask.

In one or more embodiments, a kit for use with a respiratory maskincludes at least one liner including a liner body constructed from anabsorbent material, the liner body having an outer edge, an inner edge,and an opening bounded by the inner edge. The kit further includes atleast one retaining member arranged to be connected to the respiratorymask, the at least one retaining member including at least one engagingmember for receiving the liner and tethering the liner to therespiratory mask.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a top plan view of a liner according to an embodiment, such asfor use with a respiratory mask;

FIG. 2 is a top plan view of a liner according to another embodiment;

FIG. 3 is a top plan view of a liner according to yet anotherembodiment;

FIG. 4 is a perspective view of a retaining member according to anembodiment;

FIG. 5 is a top plan view of the retaining member;

FIG. 6 is a top perspective view of the retaining member connected to atop side of a respirator;

FIG. 7 is a rear view of the retaining member connected to the top sideof a respirator;

FIG. 8 is front perspective view of the retaining member connected tothe top side of a respirator;

FIG. 9 is a side view of the retaining member connected to a respirator;

FIG. 10 illustrates a liner retained on a respirator;

FIG. 11 is a top view of the liner engaged by the hooks of a retainingmember on the top side of a respirator;

FIG. 12 is a bottom view of the liner engaged by the hooks of aretaining member on a bottom side of a respirator;

FIG. 13 is a top perspective view of a retaining member on a CPAP mask;

FIG. 14 is perspective view of a retaining member on an oxygen mask; and

FIG. 15 is a perspective view of a retaining member according to anotherembodiment.

DETAILED DESCRIPTION

As required, detailed embodiments of the present invention are disclosedherein; however, it is to be understood that the disclosed embodimentsare merely exemplary of the invention that may be embodied in variousand alternative forms. The figures are not necessarily to scale; somefeatures may be exaggerated or minimized to show details of particularcomponents. Therefore, specific structural and functional detailsdisclosed herein are not to be interpreted as limiting, but merely as arepresentative basis for teaching one skilled in the art to variouslyemploy the present invention.

Embodiments disclosed herein provide a respiratory mask and accessoriesfor use with a respiratory mask which are capable of improving thecomfort, effectiveness, and/or user compliance of respiratory masks.

With reference to FIGS. 1-3 , a liner for use with a respiratory mask,such as a respirator 100 (see FIGS. 6-12 ), is illustrated anddesignated generally by reference numeral 10. In use, the liner 10 maybe positioned between the respiratory mask and the face of a user, suchas to absorb moisture, maintain proper positioning of the respiratorymask, and to greatly reduce or eliminate air from leaking between therespiratory mask and the user's face. Although the liner 10 is describedherein primarily in relation to use with a respirator 100, it isunderstood that the liner 10 is not limited to use with respirators, andthat the description provided herein is equally applicable to use of theliner 10 with other types of respiratory masks such as, but not limitedto, CPAP masks 200 (see FIG. 13 ) or oxygen masks 300 (see FIG. 14 ).

In one embodiment, the liner 10 includes a liner body 12 having an outeredge 14, an inner edge 16, and an opening 18 bounded by the inner edge16. The liner body 12 may be generally oval-shaped, elliptical, round,or triangular, or have any other shape appropriate for use with arespiratory mask and is not limited to the shapes depicted herein. Theopening 18 is designed to at least partially receive the nose, mouth, orboth nose and mouth, depending upon the type of respiratory mask. Theopening 18 may be generally elliptical or oval-shaped as shown, but isnot intended to be limited to these shapes.

With reference now to FIGS. 4 and 5 , a retaining member 50 can beconnected to the respiratory mask and provided to receive and engage theliner 10, allowing the liner 10 to be tethered to the respiratory maskand to be retained in a desired position with respect to the respiratorymask. The retaining member 50 includes a body, which in one embodimentmay be an elongated body 52 having a central portion 54 and opposingends 56 on either side of the central portion 54. The retaining member50 further includes at least one engaging member, which in oneembodiment may include a post or hook 60 having a proximal end 62 and adistal end 64, where one hook 60 may be provided at or near each end 56of the body 52. The retaining member 50 and included hooks 60 may beconstructed from any suitably flexible and durable material, such as aplastic or rubber material. Resilience of the retaining member 50 andhooks 60 may be advantageous in conforming the elongated body 52 to therespiratory mask, engaging and retaining the liner 10, and preventingdamage of the retaining member 50 in the event that an external force isapplied to the retaining member 50 during use of the respiratory mask.As shown, the central portion 54 of the body 52 may be narrower than theends 56, which may also facilitate flexibility of the retaining member50. The central portion 54 may also include a marker 66 identifying acenter of the body 52 for facilitating alignment and symmetricalplacement on the respiratory mask. Although an elongated body 52 isshown herein, the body 52 is not limited to this configuration, and itis contemplated that the body 52 could alternatively have other shapeswith one or more engaging members extending therefrom.

In one embodiment, each hook 60 extends upwardly from the body 52 at itsproximal end 62, and then extends outwardly or laterally with respect tothe body 52 to terminate in the distal end 64, where the distal end 64may extend beyond the body 52. The hooks 60 may have rounded distal ends64 and may have narrower distal ends 64 compared with the proximal ends62, both of which may facilitate receiving and retaining the liner 10 onthe retaining member 50. Of course, the retaining member 50 and thehooks 60 are not limited to the configuration shown and describedherein. For example, instead of two spaced hooks 60, it is contemplatedthat only one hook or more than two hooks could be provided. Inaddition, the post or hook 60 may have a different configuration, suchas extending upwardly from the body 52 and having a narrower proximalend 62 compared with the distal end 64. The retaining member 50 mayalternatively include another type of engaging member altogether, suchas a clip 68 (e.g., hinged, spring-loaded, alligator, etc.) or the likeas illustrated in FIG. 15 .

As shown in FIGS. 1 and 2 , the liner 10 may have one or more aperturessized to be received by the hooks 60 for tethering the liner 10 to therespiratory mask and retaining a desired position of the liner 10. Inthe illustrated embodiment, a first or top pair of spaced apertures 70may be adjacent a first end 72 of the liner 10, and a second or bottompair of spaced apertures 74 may be adjacent a second end 76 of the liner10. The first and second pairs of apertures 70, 74 may be generallycircular or oval-shaped as shown, but are not intended to be limited tothese shapes. The configuration of the apertures 70, 74 can be designedto correspond to the configuration of the hooks 60 and the retainingmember 50. As such, although a pair of apertures 70, 74 is shown at eachend 72, 76 of the liner 10, the liner 10 is not limited to thisembodiment. Alternatively, for example, apertures may be provided ononly one end 72, 76 of the liner 10, or a single aperture or more thantwo apertures may be provided at one or both ends 72, 76 or on otherportions of the liner 10.

Turning to FIGS. 6-9 , the retaining member 50 may be connected to arespiratory mask, such as a respirator 100, having a mask body 102 witha front side 104, a rear side 106, a top side 108, and a bottom side110. As shown, in one embodiment the hooks 60 may be oriented toward therear side 106 of the respiratory mask, away from a face-engaging portion112 on the front side 104. The retaining member 50 can be affixed to therespiratory mask by any method, such as with an adhesive or with a hookand loop material to join a bottom surface 69 of the retaining member 50to the mask body 102. The retaining member 50 can be removably attachedto the mask body 102 so that it can be repositioned or removed ifnecessary. Alternatively, the retaining member 50 could be integrallyformed with the mask body 102 during manufacturing, such as viainjection molding. In another embodiment, a kit including one or moreliners 10 and retaining members 50 could be provided for use inretrofitting a respirator 100, CPAP mask 200, oxygen mask 300, or otherrespiratory mask.

FIGS. 10-12 depict a liner 10 tethered to a respirator 100 via one ormore retaining members 50. FIG. 10 illustrates alignment of the opening18 with the face-engaging portion 112, wherein retaining members 50 canbe positioned on the mask body 102 with placements that engage andproperly align the liner 10 to generally overlie the face-engagingportion 112. FIG. 11 illustrates engagement of the first pair ofapertures 70 with a retaining member 50 on the top side 108 of therespirator 100, and FIG. 12 illustrates engagement of the second pair ofapertures 74 with a retaining member 50 on the bottom side 110 of therespirator 100, such that the liner 10 is retained in a desired positionwith respect to the respirator 100. While retaining members 50 are shownpositioned on the top and bottom sides 108, 110 of the mask body 102, itis understood that retaining members 50 could additionally oralternatively be positioned on the side or other regions of therespiratory mask and corresponding apertures formed in differentportions of the liner 10.

The features of respirator 100 described above with reference to FIGS.6-12 may also be applicable to the CPAP mask 200 shown in FIG. 13 andthe oxygen mask 300 shown in FIG. 14 , wherein the respiratory maskfeatures described for respirator 100 are given like reference numeralswith the substitution of a “2” prefix for the CPAP mask 200 and with thesubstitution of a “3” prefix for the oxygen mask 300.

The outer edge 14 of liner 10 may have a shape scaled to a general shapeof the face-engaging portion 112, 212, 312 (see, for example, FIGS. 8and 13-14 ) of the respiratory mask 100, 200, 300. As best shown in FIG.10 , a perimeter of the liner outer edge 14, which may be continuous ordiscontinuous, is larger than a perimeter of the face-engaging portion112, wherein the outer edge 14 extends outwardly beyond theface-engaging portion 112 around at least part of the perimeter of theface-engaging portion 112. As such, as illustrated in an exemplarymanner in FIGS. 1 and 3 by the broken line, the liner body 12 has afirst portion 20 which will be disposed inward of the perimeter of theface-engaging portion 112 when the liner 10 is tethered to therespiratory mask, and a second, extending portion 22 which will bedisposed outward of the perimeter of the face-engaging portion 112 in afreely extendible manner when the liner 10 is tethered to therespiratory mask. In general, the area of the extending portion 22 maycomprise at least about 5%, 10%, or 15% of the area of the liner body12, but larger proportions of area represented by the extending portion22 are also contemplated.

Once the liner 10 is engaged by the retaining member 50 on therespiratory mask 100, 200, 300, the user may fit his/her nose and/ormouth (as applicable) into the opening 18 and secure the respiratorymask to his/her head, such as with straps. Securing the respiratory maskreleasably holds the liner 10 between the face-engaging portion 112,212, 312 and a user's face, such that the liner 10 may regulate air flowand reduce air leaks between the face-engaging portion and the user'sface. The liner 10 may be adjusted if necessary, such as around the noseand mouth, by pulling outward on the protruding extending portion 22while the respiratory mask is secured, thereby providing a customizedfit for a particular user. The liner 10 is held in place by theretaining member 50 as well as the pressure of the respiratory mask uponthe user's face, and the liner 10 is easily removable and replaceablewhen the respiratory mask is removed. The outer edge 14 and extendingportion 22 will extend outwardly from the face-engaging portion 112,212, 312 and may generally follow the contours of the user's face. Theouter edge 14 of the liner 10 loosely protrudes beyond the face-engagingportion such that the extending portion 22 may be in non-adhering,non-sealing communication with a user's face. In this manner, the liner10 and its extending portion 22 may serve to reduce air leaks from theperimeter of the face-engaging portion by acting as a baffle toregulate, limit, or diffuse air flow between the respiratory mask andthe skin.

During use, it may be necessary for the user to remove the respiratorymask temporarily. For example, a user may wish to remove a respirator100 in certain instances, such as to have a conversation with acoworker, to drink or eat, or to take a break during a job. A CPAP usermay wish to remove his/her CPAP mask 200 while in use, such as duringthe night to use the restroom or to get a drink of water. In a hospitalor home setting, a user may need to have an oxygen mask 300 removed fora temporary period, such as to eat, drink, or take medication. Accordingto the embodiments disclosed herein, when the user removes therespiratory mask, the liner 10 is retained in position on therespiratory mask by the retaining member 50. Accordingly, if a userneeds to remove the respiratory mask for any reason, the user will nothave to reposition or replace the liner 10 when he/she puts therespiratory mask on again. When the user does wish to replace the liner10, the liner 10 is disposable and may be easily removed from theretaining member 50, discarded, and then replaced with another liner 10.Advantageously, use of the liner 10 prevents direct skin contact withthe mask material, decreasing the need to clean the respiratory mask asfrequently.

Since the apertures 70, 74 may be provided in the extending portion 22of the liner 10, the apertures 70, 74 do not alter the function of theliner 10 or its interface with the face-engaging portion 112, 212, 312.As such, the liner 10 described herein can be used with a respiratorymask whether or not a retaining member 50 is associated with therespiratory mask or whether or not engagement of the liner 10 with aretaining member 50 is utilized. The apertures 70, 74 do not increasethe overall footprint of the liner 10, and do not require the liner 10to be manufactured with auxiliary attachment members. However,alternative embodiments are also contemplated where instead of or inaddition to having apertures 70, 74 in the extending portion 22 setinwardly from the liner outer edge 14, the extending portion 22 mayinclude loops or tabs 80 which extend outwardly from the liner outeredge 14 and include apertures 70, 74 as illustrated in FIG. 3 . Stillfurther, such tabs/loops 80 or other portions of the liner 10 couldinclude adhesive for removably affixing the liner 10 to part of therespiratory mask. In an embodiment where the engaging member includes aclip-type structure instead of a hook 60, a liner 10 without apertures70, 72 could be utilized.

According to an embodiment, the liner body 12 may be constructed from asingle layer of absorbent material, wherein the thickness of the linerbody 12 may be between about 0.005 to 0.05 inches, although thesedimensions are not intended to be limiting. In one embodiment, thematerial may include cotton. In another embodiment, the material mayinclude another material, such as silicone, with cotton embeddedtherein. However, it is understood that any material with suitableabsorption and comfort properties may be used. In further accordancewith an embodiment, the material used for the construction of the linerbody 12 may be stretchable to aid in adjusting and customizing the fitof the liner 10 to a particular user as described above. The liner 10may also include a notch 78 or indented section at one end 72 thereof tocorrespond with the nose region of a user, which may provide a moreunobstructed line of sight for the user when the liner 10 is retained inposition on the respiratory mask.

Copper is a natural mineral having human nutritional benefit. Copper isalso known to provide antimicrobial and potential wound healingproperties. In one embodiment, the liner described herein may bemanufactured with a copper or copper oxide material, such as CUPRON®.

Due to the moisture content of the air, facial perspiration (such as dueto contact with the mask material), and oil from the skin, therespiratory mask 100, 200, 300 may slip on the user's face, thus leakingair. The absorbent material of the liner 10 may function to absorbmoisture and/or oils from the user's skin and wick it away from the faceand the face-engaging portion 112, 212, 312, enabling the respiratorymask to maintain a consistent and comfortable position with respect tothe user's face when in use. As a result, proper positioning of theface-engaging portion with respect to the user's skin may be maintained,thus eliminating or greatly reducing air leaks and facilitating theability for a user to wear their respiratory mask more comfortably.

The single layer construction of the liner 10 may act as a sort of“second skin” upon the user's face. As such, the liner 10 is able toprovide its functions without detracting from the prescribed fit of therespiratory mask 100, 200, 300 since the liner 10 does not appreciablyalter the distance of the face-engaging portion 112, 212, 312 from theuser's face. Pressure markings from the face-engaging portion on auser's face may also be reduced or eliminated by use of the liner 10.Furthermore, the absorbent liner material may make use of facial creamspossible while wearing a respiratory mask, since direct contact of theskin with the mask material is avoided.

Respiratory masks are offered in various shapes and sizes, includingfull-face, nasal, child-sized, and partial-face (hybrid) configurations.Full-face masks typically include a wider bottom region for covering themouth area and a narrower upper region for covering the nasal area.Nasal masks generally cover the nasal area and not the mouth area.Child-sized masks may have a proportionally smaller size. Partial-face(hybrid) masks generally cover the mouth and may include a nasalinterface. It is therefore contemplated that the outer edge 14 of liner10 may have a shape similar to a general shape of the face-engagingportion for a selected respiratory mask, wherein the shape of the outeredge 14 may represent a scaled version of the general shape of theface-engaging portion.

The liner 10 and the retaining member 50 disclosed herein may facilitatea more comfortable and effective mask-wearing experience for the user bycontributing to a good fit of a respiratory mask, providing comfort tothe user, eliminating moisture, and reducing or eliminating air leaks.Furthermore, tethering the liner 10 to the respiratory mask via theretaining member 50 makes it easy to remove the respiratory masktemporarily and then secure the mask at a later time without having toreposition or replace the liner 10.

While exemplary embodiments are described above, it is not intended thatthese embodiments describe all possible forms of the invention. Rather,the words used in the specification are words of description rather thanlimitation, and it is understood that various changes may be madewithout departing from the spirit and scope of the invention.Additionally, the features of various implementing embodiments may becombined to form further embodiments of the invention.

What is claimed is:
 1. A respiratory mask, comprising: a mask bodyhaving a face-engaging portion; and at least one retaining memberconnected to the mask body, the at least one retaining member includinga flexible elongated body and at least one engaging member, the flexibleelongated body having a central portion and opposing ends on either sideof the central portion, wherein the central portion is narrower than theopposing ends, the at least one engaging member extending upwardly fromthe flexible elongated body and configured for receiving a liner andtethering the liner to the respiratory mask to generally overlie theface-engaging portion.
 2. The respiratory mask of claim 1, wherein theat least one retaining member is removably attached to the mask body. 3.The respiratory mask of claim 1, wherein the at least one retainingmember is integrally formed with the mask body.
 4. The respiratory maskof claim 1, wherein the at least one engaging member includes a hook. 5.The respiratory mask of claim 1, wherein the at least one engagingmember includes a clip.
 6. A retaining member for use with a respiratorymask, the retaining member comprising: a flexible elongated body havinga central portion and opposing ends on either side of the centralportion, wherein the central portion is narrower than the opposing ends,the flexible elongated body having a bottom surface arranged to beattached to the respiratory mask; and at least one engaging memberextending upwardly from the flexible elongated body and configured forreceiving a liner and tethering the liner to the respiratory mask. 7.The retaining member of claim 6, wherein the at least one engagingmember includes at least one hook.
 8. The retaining member of claim 6,wherein the at least one engaging member includes at least one clip. 9.The retaining member of claim 6, wherein the at least one engagingmember includes an engaging member provided at each of the opposing endsof the flexible elongated body.
 10. The retaining member of claim 6,wherein the central portion includes a marker for identifying a centerof the body.
 11. A kit for use with a respiratory mask, comprising: atleast one liner including a liner body constructed from an absorbentmaterial, the liner body having an outer edge, an inner edge, and anopening bounded by the inner edge; and at least one retaining memberarranged to be connected to the respiratory mask, the at least oneretaining member including a flexible elongated body and at least oneengaging member, the at least one engaging member extending upwardlyfrom the flexible elongated body and configured for receiving the linerand tethering the liner to the respiratory mask, wherein the liner bodyincludes at least one aperture arranged to be received by the at leastone engaging member.
 12. The kit of claim 11, wherein the at least oneengaging member includes a hook.
 13. The kit of claim 11, wherein the atleast one engaging member includes a clip.
 14. The kit of claim 11,wherein the at least one aperture includes a first pair of spacedapertures adjacent a first end of the liner.
 15. The kit of claim 11,wherein the at least one aperture includes a first pair of spacedapertures adjacent a first end of the liner and a second pair of spacedapertures adjacent a second end of the liner.
 16. The kit of claim 11,wherein the liner includes at least one tab extending outwardly from theouter edge of the liner body.
 17. The kit of claim 16, wherein at leastone aperture is provided in the at least one tab.
 18. The kit of claim11, wherein the liner body includes a notch at one end thereof.